Market Penetration of Laser Therapy in Venous Surgery: ZOL - ZMK Center Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duomed
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
Study Overview
Brief Summary
The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is at least 18 years old.
- •Patient must sign and date the informed consent form prior to treatment.
- •Presence of unilateral or bilateral primary or recurrent symptomatic varicose veins (CEAP grade ≥ C2).
- •Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).
Exclusion Criteria
- •Current deep vein thrombosis.
- •Acute superficial thrombosis.
- •Coagulopathy or bleeding disorders.
- •Contraindications to the use of general or regional anesthesia.
Outcomes
Primary Outcomes
To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins.
Time Frame: At 6 weeks follow-up
The participating investigators will re-evaluate the chosen treatment option and document this re-evaluation in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged.
Secondary Outcomes
- Pain scoring using the Visual Analog Scale (VAS)(At 6 weeks follow-up)
- Anatomic success of EndoVenous Laser Ablation (EVLA)(At 6 weeks follow-up)
- Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ)(At 6 months follow-up)
- Post-operative adverse events(At 6 months follow-up)
- Re-interventions(At 6 months follow-up)
- Procedural characteristics(At index-procedure)